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Summary

  • Graduated with a PhD in Molecular Biology, I have gained strong knowledge regarding angiogenesis process (VEGF, Cellular Pathways) during tumor development (especially Breast Cancer) and siRNA/miRNA development.
  • For 10 years I have been in charge of setting up and managing clinical trials as a Clinical Project Manager across Europe and Middle East in various therapeutic areas. This has allowed me to gain strong KOL networks in different therapeutic areas and to gain a real expertise in clinical trials development/management in addition to Medical Affairs strategy.
  • MSL since June 2010, I became afterwards MSL Manager (Europe) in April 2013 for Bavarian Nordic. This line management experience has then been strengthen when I took the responsibility for the European clinical development of two Biomarkers Assays for two Companies (Inivata Ltd and Oncoplex Dx) with a focus on NSCLC/Breast and a team of 10 people to manage across Europe.
  • Currently I am responsible for the Launch of two Products in infectious disease (Antibiotics / Antifungal) and responsible for a team of 15 people (France and Middle East).
  • Involved in both pre and post-launch activities which has enabled me to build relationships with physicians identified as KOLs alongside colleagues in order to educate the field sales force.
  •  I am specialized in setting up Investigator Sponsored Studies due to my strong background in clinical trials management.
  • Organized, diplomatic and take pride in having expert knowledge of my products which leads to the success of your product launch/development.

Experiences

Current Experience

  • Country Medical Affairs Leader Paris, France
    Since April 2016

    Currently I am responsible for the Launch of two Products in infectious disease (Antibiotics / Antifungal) and responsible for a team of 15 people (France and Middle East).

    • Responsible of defining / implementing the Medical Affairs strategy in France
    • Discussion / Lunch of IITs – Feasibility of company sponsored trials
    • Management Team 3 MSLs – 8 KAMs
    • Advisory Board set up / Management
    • Development of educational program (internal/external)
    • Congress strategy set up

  • CEO
    Since September 2009
    My company is based in UAE and we cover Middle east and Europe regarding all Clinical Study activities including but not limited to: - Monitoring Phase II-IV several clinical trials with paediatrics and adults patients - Site contract negotiations (Hospital, Investigator fees) - Site initiation and co-ordination Interim monitoring visits, Site management, Site close-outs - Serious Adverse Event reporting, follow up, reconciliation (Meddra) - Regulatory submissions - Vendors management (For SAE, eCRF, Samples, IVRS, MRI, Scanner, Drug shipment...) - SOPs Writing (for Quality assurance Depatment) - Medical Writing, Preparation of study documents (ICFs, CRF...)

Past Experience

  • Global Medical Affairs Manager - Europe
    April 2015 --- April 2016

    In charge of developing/maintaining clinical collaborations with Pharma companies and KOLs across Europe. Attend key congresses in US and Europe. Deep knowledge of NSCLC landscape and associated treatment algorithm.

  • Clinical Development Consultant - Europe
    October 2014 --- September 2015
    In charge of developing/maintaining clinical collaborations with KOLs based in France and UK. Attend key congresses in US and Europe. Management of Investigator Sponsored Studies using NGS/Liquid Biopsy and determination of clinical utilities (mainly in Lung and Breast Cancer). Development/conception of international observational study.

  • Manager, Medical Affairs and Clinical Development - Europe
    April 2013 --- March 2015
    I have a strong KOLs network across Europe within Prostate Cancer (Mainly in UK, France and Belgium). I am an expert of Castrate Resistant Prostate Cancer field (including but not limited to Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium 223, denosumab, Cabozantinib, ARN509, Tasquinimod, Orteronel, Sipuleucel-T, LHRH agonist/antagonist ….) My main responsibilities are: - Scientific & medical communication in oncology adressed to UK, Belgium and French hospitals stakeholders (KOL & Health care professionnals) for an innovative Vaccine in mCRPC patients. - Develop the company notoriety deploying adapted communication to create a favorable environment for the market access. - Training CRA/MSL - Attend all major congress in Europe in relation with Prostate Cancer. - Advisory board animation management / Stand alone meeting organization / Patient association partnership.

  • Medical Writer
    October 2010 --- March 2013
    Freescience is a Network of Four Freelance Medical Writers who can offer on a freelance basis: - Conception/Design of Scientific Research Projects (Protocol design and writing, Case Report Form Design, Investigator Brochure writing, Informed patient leaflet) - Analysis/ Reporting of Scientific Data (Clinical Study Report, Bridging data packages, Pharmacovigilance report (PSUR), Common Technical Document (Module2 and 5)) - Communication/Scientific Information (Publication, Product monograph Symposium coverage, Abstracts, Posters, Slides, Newsletters, Word and Image processing, Graphs, Illustrations, Drawing, Translation (English/French – French/English)

  • Medical Science Liaison (MSL) Europe - Oncology and Medical Device
    June 2010 --- March 2013
    As a Medical Sciance Liaison (MSL) covering Europe, I am mainly in charge of: - Discussing and providing scientific and therapeutic information to professionals and researchers in the healthcare industry / Hospitals (KOLs) - Developping and maintaining strong relationships with clinicians and scientists - Creating early awareness and acceptance of the scientific evidence in support of new and existing products and claims - Researching and providing relevant scientific information to professionals - Setting up Investigators Sponsores Studies and discussing with KOLs how to conduct such studies. - Training of sale teams - Conducting/Setting up Advisory Boards

  • Clinical Project Manager (CPM)
    October 2008 --- October 2009
    Managment of clinical trials in Europe from feasability to final report. Writing of trial documents (Consentement, Monitoring Guidelines ...) for international studies.

  • Clinical Research Associate (CRA)
    October 2007 --- September 2008
    Outsourcing within Baxter SAS Setting up of Phase IIIb study in elderly people

  • Clinical Research Associate (CRA)
    April 2007 --- August 2007
    Monitoring of a Phase III Study in Saudi Arabia. Meningococcal vaccine - Adult and Paediatric - 7 sites (around 40 patients per site)

Knowledge

LinkedIn Assessment :
DiplomacyOrganisational skillsoncologyCardiologyMedical DevicesClinical NutritionClinical trialsHealth EconomicsMedical affairsProgram ManagementPatient AdvocacyProject ManagementClinical monitoringCROKOL IdentificationKOL developmentTherapeutic AreasMedical EducationPharmacovigilanceClinical researchMedical writingBiotechnologyClinical DevelopmentICH-GCPRegulatory submissionsCTMSVaccinesUrologyClinical Study DesignEndocrinologySOPmolecular biologyDermatologyImmunologyLifesciencesDrug DevelopmentRegulatory affairsMedicineGCPInfectious diseasesPharmaceutical IndustryPharmaceuticsDiabetesBiopharmaceuticalsCancerHematologySOPLife SciencesLeadership

Skills and Expertise

Self Assessment :
clinical researchMedical Affairsoncologyimmuno-oncologylungprostatebreasthaematologyclinical trialInteract with KOLPresent data at congressmedical writingliquid biopsyBiomarkersSet up a clinical study

Education

  • PhD in Oncology -Effect Extracellular Matrix in Breast Cancer from Université de Reims Champagne-Ardenne in 2007

Training and Certification

  • InfocusRX Certification

Languages

BrightOwl Assessment:
Self Assessment:
Arabic
Elementary Proficiency
French
Native
English
Native

Area / Region

Nancy, France

Others

Driving License
  • Yes